Maternal Brain Imaging in Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI.
研究概览
简要总结
This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant Women with OUD
- •Inclusion Criteria:
- •Age: >18 years old
- •Any subject that is currently on Buprenorphine at time of screening
- •Singleton pregnancy
排除标准
- •Serious maternal medical illness
- •HIV or AIDs
- •Polysubstance use
- •Score >9 on the PHQ-9, and score >0 on item 9 which is about suicidality
- •Score of 8 or more on GAD-7
- •Any contraindications for MRI
- •Known or suspected major fetal congenital abnormalities
- •Pregnant Women with no history of OUD
- •Age: >18 years old
- •Singleton pregnancy
- •Serious maternal medical illness
- •HIV or AIDS
- •Score of >9 on the PHQ-9, and a score of >0 on item 9 which is about suicidality
- •Score of 8 or more on GAD-7
- •Known or suspected major fetal congenital abnormalities
- •Any contraindications for MRI
- •Opioid or polysubstance abuse as identified on urine screening
研究组 & 干预措施
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
干预措施: Buprenorphine (Drug)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
干预措施: Maternal Brain MRI (Diagnostic Test)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
干预措施: Blood Samples (Other)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
干预措施: Questionnaires (Behavioral)
Pregnant Mothers
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
干预措施: Maternal Brain MRI (Diagnostic Test)
Pregnant Mothers
Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI.
时间窗: During MRI visit between 24-32 weeks gestational age
次要结局
- Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD(During MRI visit between 24-32 weeks gestational age)
研究者
Rupa Radhakrishnan
Associate Professor of Radiology & Imaging Sciences
Indiana University